Home Applications 018671 Application 018671
Type NDA
Sponsor CARDINAL HEALTH 418 Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 SODIUM IODIDE I 123 SODIUM IODIDE I-123 CAPSULE;ORAL 100uCi Yes Yes 002 SODIUM IODIDE I 123 SODIUM IODIDE I-123 CAPSULE;ORAL 200uCi Yes Yes 003 SODIUM IODIDE I 123 SODIUM IODIDE I-123 CAPSULE;ORAL 400uCi No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N018671-001 SODIUM IODIDE I 123 SODIUM IODIDE I-123 100uCi CAPSULE / ORAL AA RLD, RS 1982-05-27 N018671-002 SODIUM IODIDE I 123 SODIUM IODIDE I-123 200uCi CAPSULE / ORAL AA RLD, RS 1982-05-27 N018671-003 SODIUM IODIDE I 123 SODIUM IODIDE I-123 400uCi CAPSULE / ORAL 1982-05-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 4 · 123 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N018671-001 SODIUM IODIDE I 123 100uCi CAPSULE / ORAL AA RLD, RS 1982-05-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018671-002 SODIUM IODIDE I 123 200uCi CAPSULE / ORAL AA RLD, RS 1982-05-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018671-003 SODIUM IODIDE I 123 400uCi CAPSULE / ORAL 1982-05-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018671-001 SODIUM IODIDE I 123 100uCi CAPSULE / ORAL AA RLD, RS 1982-05-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018671-002 SODIUM IODIDE I 123 200uCi CAPSULE / ORAL AA RLD, RS 1982-05-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018671-003 SODIUM IODIDE I 123 400uCi CAPSULE / ORAL 1982-05-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N018671-001 SODIUM IODIDE I 123 100uCi CAPSULE / ORAL AA RLD, RS 1982-05-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N018671-002 SODIUM IODIDE I 123 200uCi CAPSULE / ORAL AA RLD, RS 1982-05-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N018671-003 SODIUM IODIDE I 123 400uCi CAPSULE / ORAL 1982-05-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018671-001 SODIUM IODIDE I 123 100uCi CAPSULE / ORAL AA RLD, RS 1982-05-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018671-002 SODIUM IODIDE I 123 200uCi CAPSULE / ORAL AA RLD, RS 1982-05-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018671-003 SODIUM IODIDE I 123 400uCi CAPSULE / ORAL 1982-05-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018671-001 SODIUM IODIDE I 123 100uCi CAPSULE / ORAL AA RLD, RS 1982-05-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018671-002 SODIUM IODIDE I 123 200uCi CAPSULE / ORAL AA RLD, RS 1982-05-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018671-003 SODIUM IODIDE I 123 400uCi CAPSULE / ORAL 1982-05-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018671-001 SODIUM IODIDE I 123 100uCi CAPSULE / ORAL AA RLD, RS 1982-05-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018671-002 SODIUM IODIDE I 123 200uCi CAPSULE / ORAL AA RLD, RS 1982-05-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018671-003 SODIUM IODIDE I 123 400uCi CAPSULE / ORAL 1982-05-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018671-001 SODIUM IODIDE I 123 100uCi CAPSULE / ORAL AA RLD, RS 1982-05-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018671-002 SODIUM IODIDE I 123 200uCi CAPSULE / ORAL AA RLD, RS 1982-05-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018671-003 SODIUM IODIDE I 123 400uCi CAPSULE / ORAL 1982-05-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018671-001 SODIUM IODIDE I 123 100uCi CAPSULE / ORAL AA RLD, RS 1982-05-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018671-002 SODIUM IODIDE I 123 200uCi CAPSULE / ORAL AA RLD, RS 1982-05-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018671-003 SODIUM IODIDE I 123 400uCi CAPSULE / ORAL 1982-05-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018671-001 SODIUM IODIDE I 123 100uCi CAPSULE / ORAL AA RLD, RS 1982-05-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018671-002 SODIUM IODIDE I 123 200uCi CAPSULE / ORAL AA RLD, RS 1982-05-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018671-003 SODIUM IODIDE I 123 400uCi CAPSULE / ORAL 1982-05-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N018671-001 SODIUM IODIDE I 123 100uCi CAPSULE / ORAL AA RLD, RS 1982-05-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N018671-002 SODIUM IODIDE I 123 200uCi CAPSULE / ORAL AA RLD, RS 1982-05-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N018671-003 SODIUM IODIDE I 123 400uCi CAPSULE / ORAL 1982-05-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018671-001 SODIUM IODIDE I 123 100uCi CAPSULE / ORAL AA RLD, RS 1982-05-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018671-002 SODIUM IODIDE I 123 200uCi CAPSULE / ORAL AA RLD, RS 1982-05-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018671-003 SODIUM IODIDE I 123 400uCi CAPSULE / ORAL 1982-05-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018671-001 SODIUM IODIDE I 123 100uCi CAPSULE / ORAL AA RLD, RS 1982-05-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018671-002 SODIUM IODIDE I 123 200uCi CAPSULE / ORAL AA RLD, RS 1982-05-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018671-003 SODIUM IODIDE I 123 400uCi CAPSULE / ORAL 1982-05-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N018671-001 SODIUM IODIDE I 123 100uCi CAPSULE / ORAL AA RLD, RS 1982-05-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N018671-002 SODIUM IODIDE I 123 200uCi CAPSULE / ORAL AA RLD, RS 1982-05-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N018671-003 SODIUM IODIDE I 123 400uCi CAPSULE / ORAL 1982-05-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N018671-001 SODIUM IODIDE I 123 100uCi CAPSULE / ORAL AA RLD, RS 1982-05-27 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 2 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 48815-1001 Sodium Iodide I 123 Sodium Iodide I 123 Cardinal Health 418, Inc NDA Current 48815-1002 Sodium Iodide I 123 Sodium Iodide I 123 Cardinal Health 418, Inc NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 33552 SUPPL 2008-06-18 15085 SUPPL 2008-06-17